Training workload in the investigational drug service of a university hospital center.

PURPOSE: Training represents a considerable portion of research activities and is vastly different for each clinical trial. This variation is partially explained by the lack of detailed regulations surrounding training procedures, which hinders the ability of investigational drug service (IDS) staff to plan their workload. The aim of this study was to quantify the workload associated with trial-specific training of IDS staff. The secondary aim was to identify the factors associated with training complexity. METHODS: A retrospective study was carried out in the IDS of a mother and child university hospital. Trial-specific documents on which the pharmacy staff was trained were analyzed. Workload was calculated by measuring reading time. The readability of each document was determined by the Flesch Reading Ease score. The complexity of the trials was established using the scoring method of Calvin-Lamas et al. The influence of the following factors on training was assessed by analysis of variance: sponsor type, research phase, and research focus by medical specialty. RESULTS: A total of 93 clinical trials and 433 documents were included. Investigator's brochures were the longest (a mean [SD] of 107 [46] pages; P < 0.0001) and most difficult documents to read (mean [SD] readability score, 25.5 [4.4]; P < 0.0001). Trials with industry sponsors required a significantly longer overall reading time (mean [SD], 12.26 [6.72] hours; P < 0.0001). On average, a mean (SD) of 9.42 (7.16) hours of reading were necessary to train one employee for a clinical trial. CONCLUSION: This study is the first to document reading time necessary for training of IDS staff. The training workload varied by sponsor type, while the research phase and medical specialty had little impact. IDS units would benefit from a tool that could identify complex trials.

Examining Indigenous food sovereignty as a conceptual framework for health in two urban communities in Northern Ontario, Canada.

While land is a nexus for culture, identity, governance, and health, as a concept land is rarely addressed in conversations and policy decisions about Indigenous health and well-being. Indigenous food sovereignty, a concept which embodies Indigenous peoples' ability to control their food systems, including markets, production modes, cultures and environments, has received little attention as a framework to approach Indigenous health especially for Indigenous people living in urban spaces. Instead, discussions about Indigenous food sovereignty have largely focused on global and remote and rural communities. Addressing this gap in the literature, this article presents exploratory work conducted with Waasegiizhig Nanaandawe'iyewigamig and Shkagamik-Kwe Health Centre, two Indigenous-led Aboriginal Health Access Centres in urban service centers located in Northern Ontario, Canada.